What is an investigational drug? Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms investigational drug and investigational new drug are deemed to be synonymous for purposes of this part.
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Charging for and commercialization of investigational drugs The terms. ''investigational drug'', ''investigational new drug'' and
Jump to: Investigational Drugs, Medical Devices. Investigational Drugs. What is Is your drug clinical investigation exempt from Investigational New Drug (IND)
Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms investigational drug and investigational new drug are deemed to be synonymous for purposes of this part. (.3(b))
Investigational New Drug (IND) Application. An IND application is an application to the FDA that allows an investigational drug or biological product to be studied in humans. An IND application must be in effect prior to shipment and administration of investigational drugs or biological products (see ). s. Investigational Supply.
Investigational Drugs and Devices (IND/IDE) As defined by the Food and Drug Administration (FDA), an IND, or investigational new drug application, is a request for authorization from the FDA to administer an investigational drug or biological product to humans.
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Handles narcotics complaints, mid-level drug investigations, vice/human trafficking investigations and investigations outside of the scope of patrol division
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